INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo SOPENTAL TABLETS
SOPENTAL CAPSULES

SCHEDULING STATUS:
S6

PROPRIETARY NAME
(and dosage form):

SOPENTAL TABLETS
SOPENTAL CAPSULES

COMPOSITION:
Tablets or capsules each containing 100 mg
Pentobarbitone sodium

PHARMACOLOGICAL CLASSIFICATION:
2.3 Barbiturates

PHARMACOLOGICAL ACTION:
Pentobarbitone is a short-acting barbiturate with onset of action of about 15 minutes. Effects are noticeable for up to six hours. The barbiturates are sedatives and hypnotics, depending on the dosage, owing to a specific depressant effect on the ascending reticular activating system to the cerebral cortex.

INDICATIONS:
The chief use of Pentobarbitone is as a hypnotic in insomnia caused by mild anxiety states. The onset of action is sufficiently short and there is no marked sedation on the following day. It can also be used in acute anxiety states and as a basal anaesthetic.

CONTRA-INDICATIONS:
The administration of Pentobarbitone is contra-indicated in the presence of kidney and liver disease, and where there is a family history of porphyria.

DOSAGE AND DIRECTIONS FOR USE:
Adults and children over 12 years:
One or two tablets or capsules.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The concomitant administration of other drugs, such as alcohol, tranquillisers or antihistamines will potentiate the effects of Pentobarbitone and this could lead to dangerous respiratory depression. Continued use of the barbiturates may lead to the development of tolerance and dependence; this effect is more marked with the shorter-acting barbiturates such as Pentobarbitone .

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage of Pentobarbitone, as with other barbiturates, will lead to a respiratory depression, peripheral vascular collapse, feeble heart beat, lowered body temperature, suppression of urine, and prolonged coma, with depressed or absent reflexes. Treatment aims at maintaining respiration and eliminating the drug. Artificial respiration should be instituted if necessary and oxygen administered. The stomach should be washed out. Fluid may be given intravenously and urinary output must be maintained. Respiratory depression may be treated with bemegride, picrotoxin or leptazol.

CONDITIONS OF REGISTRATION:
May be advertised to the professions only.

IDENTIFICATION:
Tablets: White oval, biconvex tablet.
Capsules: Yellow hard gelatine, with white powder.

PRESENTATION:
Tablets: 40, 100 and 500.
Capsules: 100 and 1 000.

STORAGE INSTRUCTIONS:
Store below 25°C
Protect from moisture.
KEEP OUT OF REACH OF CHILDREN.

APPLICATION NUMBERS:
Tablets: B908 (Act 101/1965)
Capsules: B892 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
LENNON LIMITED
7 Fairclough Road
Port Elizabeth
6001

DISTRIBUTED BY:
Continental Ethicals
1 Corlett Drive
Illovo
Johanesburg 2196

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
28.11.1969

First presented on this site in September 1996
Current: September 2004
Source: Pharmaceutical Industry

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